Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients

Multi-center, international, prospective, randomized, interventional, pre-market.

Subjects will be randomized on 1:1 basis to either TAVR with the Medtronic TAVR system or to SAVR. Patients will be seen at pre and post-procedure, discharge, 30 days, 6 months, 1 year, 18 months, and annually through 10 years.

The expanded use addendum is a multi-center, prospective, non-randomized continued access trial. All heart team approved subjects will be assigned to TAVR with the Medtronic TAVR system. Patients will be seen at pre and post-procedure, discharge, 30 days, and annually through 10 years. Enrollment is expected not to exceed 3660 attempted implants in the United States.

Inclusion criteria

• Severe aortic stenosis, defined as follows:

• For symptomatic patients:

Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest

• For asymptomatic patients:

• Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR
• Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
• Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%.
• Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion criteria

• Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve).
• A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:

• aspirin or heparin (HIT/HITTS) and bivalirudin
• ticlopidine and clopidogrel
• Nitinol (titanium or nickel)
• contrast media
• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Ongoing sepsis, including active endocarditis.
• Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization.
• Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery.
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment.
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• Subject refuses a blood transfusion.
• Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).
• Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions.
• Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.
• Currently participating in an investigational drug or another device trial (excluding registries).
• Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria).
• Need for emergency surgery for any reason.
• Subject is pregnant or breast feeding.
• Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
• Pre-existing prosthetic heart valve in any position.
• Severe mitral regurgitation amenable to surgical replacement or repair.
• Severe tricuspid regurgitation amenable to surgical replacement or repair.
• Moderate or severe mitral stenosis amenable to surgical replacement or repair.
• Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient.
• Bicuspid aortic valve verified by echocardiography, MDCT, or MRI.
• Prohibitive left ventricular outflow tract calcification.
• Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis.
• Aortic annulus diameter of <18 or >30 mm.
• Significant aortopathy requiring ascending aortic replacement.

For transfemoral or transaxillary (subclavian) access:

• Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV.